Introduction

Resistance to
antibiotics is hardly a new problem; ever since the advent of
penicillin and other antibiotics more than 50 years ago defiant
strains of bacteria have emerged.[1]The harrowing aspect
is that now almost every human pathogen treated with antibiotics is
showing resistance, and many doctors fear that this will only be
the tip of the iceberg.[2]After all, every
time any antibiotic is used, while it may kill the majority of the
bacteria the drug was intended to destroy, there is a likelihood
that a few germs will remain, surviving because of their resistant
traits or their ability to mutate and become resistant to
antibiotics. Once created, these resistant genes can multiply
quickly, creating new strains of bacteria that could result in the
patient’s next infection failing to respond to the previously
administered antibiotic.[3]In fact, bacteria
can reproduce about every twenty minutes, meaning resistance is
quickly spread, and the resistant strand eventually becomes the
dominant strand of that species.[4]

Many of these concerns
result from the widespread overuse and overprescription of
antibiotics.[5]Many patients and
physicians are unaware of the possible harm caused by overuse of
antibiotics, and even when the doctor is aware of the risk
antibiotics are often prescribed to placate the patient who views
antibiotics as a panacea.[6]Out of the 150
million prescriptions for antibiotics each year, one expert
comments that 50% of these are considered inappropriate
prescriptions.[7]Such misuse of
antibiotics has already resulted in new strains of previously
believed easily controlled diseases, such as tuberculosis,
dysentery, and malaria.[8]Sadly, this is far
from just a United States problem, since in many parts of the
world, such as Mexico, South America, and Southeast Asia,
antibiotics are available over-the-counter.[9]It is this constant
overuse through the years of antibiotics that have some expressing
concern of a plausible “superbug”; a micro-organism
effectively resistant to all known forms of
antibiotics.[10]

If one views a
“superbug” as a far-fetched notion, just consider some
examples. In 1941 virtually every case of the contagious killer
Staphylococcus aureus was curable with penicillin, while today
fewer than 5% of these cases are treatable with
penicillin.[11]Further consider
that today there are three life-threatening bacteria strains
(Enterococcus faecalis, Mycobacterium tuberculosis, and Psuedomonas
aeruginosa) which are resistant to all current
antibiotics.[12]Scientists still
do not entirely understand the possibilities of bacterial
reproduction, mutation, and transference of certain traits, making
it impossible to rule out or properly calculate the potential for a
“superbug”.

Modern technology and
medical practice presents even more challenging problems in the
area of antibiotic resistance, in particular in the areas of
genetic engineering and the proliferation animal drug use. In the
areas of genetically engineered foods and animal drugs a threat is
feared because of the capability of the spread of resistance in a
stealthy manner that could compromise the safety of the population
without scientists having any indicators or notice. Quite simply,
these areas are a looming threat because they are largely
unregulated and not entirely understood. While scientists can ably
predict that antibiotic use in human will lead to resistance, the
consumption of genetically engineered foods or meat tainted with
antibiotic resistant bacteria is much harder to monitor and
unpredictable as to how it will affect and spread through
humans.

Fortunately, the FDA
is in a unique position to play a role in the safe development of
the aforementioned areas. While it is not a plausible option for
the FDA to simply approve new antibiotics to combat resistance
because the rate of development is not sufficient to keep up with
the rate of newly-created resistant strains,[13]there are
alternative methods for the FDA in fighting the battle against
antibiotic resistance. This paper will analyze the problems the FDA
confronts within the fields of genetic engineering and animal drugs
as it relates to antibiotic resistance. Finally, this paper will
also suggest general strategies the FDA can pursue to address the
potential epidemic of widespread antibiotic
resistance.

Part I. Genetically
Engineered Food.

A. An
Overview

The ability to
genetically engineer crops, livestock, and microorganisms holds out
hope for better food production, distribution, and as a possible
solution to worldwide nutrition problems. In the past few years the
new genetic modification capabilities have gone from the lab to the
marketplace, sparking concerns over the implications. Indeed,
nearly 80 million acres of transgenic crops were planted worldwide
last year, including 50% of the soybean acreage in the United
States.[14]Armed with the
technological capability for genetic engineering, many fear
scientists do not have the insight to foretell or predict the
consequences of gene modification in living organisms.[15]Indeed, this is
essentially an insurmountable problem. No matter how much knowledge
and detail about a parent organism is known, any new life form is
so complex that its potential harms and risks can not be
ascertained, despite detailed knowledge about the organisms’
anatomy or lineage.[16]

For example, in
genetically engineered herbicide resistant plants scientists
anticipated little environmental risk since the plants were
unlikely to develop the invasive properties of weeds.[17]However, within
three years scientists found the herbicide resistant traits had
transferred to nearby weeds through ordinary
cross-pollination.[18]This simple
example helps illustrate the delicate and unpredictable character
of nature. Living organisms act in seemingly random and yet
interdependent ways, and even when scientists know the exact traits
of an organism or plant, they are often unable to predict the
consequences of those traits on the plant itself or the surrounding
area when the new species is introduced into the environment. It is
even more harrowing when one considers that for many genetically
engineered plants and foods the traits that might pose a danger to
nature or mankind will not even be apparent to
scientists.

While the above
example demonstrates the general concern over the complexity
involved when manipulating naturally occurring organisms, the more
specific and central concerns over genetically engineered items are
divided into three categories: economic risks, environmental risks,
and human health and safety concerns.

First, economic issues
arise because small farmers can be driven out of the market since
genetically engineered foods will be designed to be cheaper and
easier to produce on an economy of scale.[19]Smaller farmers
and those who fail to use genetically altered crops will also be
threatened because the most common pesticides, such as bacillus
thuringiensis (“Bt”), will be genetically built into
plants, altering the environment with this sustained use of Bt so
that alternative methods of farming will become obsolete due to the
immunity pests will develop to many pesticides unless present at
the abnormally high rates that will be found in genetically
engineered crops.[20]Such a use of
pesticides has been analogized to indiscriminate use of antibiotics
since the pesticides are used without regard to need or
infestation, while also threatening other life, such as the monarch
butterfly in the example of Bt.[21]The farming market
will be under the control of the biotech companies, leaving farmers
to either accept the terms of biotech companies or risk losing
their business as those farmers using genetically altered crops
drive everyone else out of the market. One company, Monsanto, has
even gone so far as to splice a soybean seed with “Terminator
Technology” so that the seed becomes sterile after a period
of time, ensuring that the farmers must order seeds every year from
the company.[22]While one could
argue a market system is better, when the threat is the
monopolization of our food supply by a few companies, regulation is
needed, less we risk the health and wallets of the
public.

Environmental risks,
the second category, relate to the discussion earlier in this
section. Because living organisms always change, adapt, and
replicate, it is an impossibility to determine the future
consequences of genetic modification.[23]Introducing
engineered plants and organisms into the food chain is inevitably
unpredictable, regardless of how much scientific data is
accumulated. One of the main environmental risks cited is that
genetically engineered plants pose a significant threat to
biodiversity once introduced into the food chain.[24]

The third category,
human health and safety, is obviously the most compelling. The type
of problems here cover the spectrum. For example, on one end there
is the possibility of the creation of irritants within everyday
food. This occurred in the mid-1980s when a new strain of celery
was produced that was highly resistant to insects.[25]Unfortunately, it
was later discovered that when people handled the celery sticks
they were developing severe skin rashes caused by the shedding of
psoralens, natural chemicals which become irritants when exposed to
sunlight.[26]On the other
extreme rests the possibly fatal or severely damaging health
effects. For an example of the extreme rhetoric and heated
controversy these types of concerns can wreak, look at the debate
over Posilac, or what is commonly called recombinant bovine
somatotrophin (rBST) or bovine growth hormone (BGH).[27]The debate over
BGH demonstrates science’s inability to accurately evaluate
genetically altered products and the potential for consumer
hostility on an international scale. For example, because of the
controversial claims that BGH has carcinogenic qualities, Canada
has banned BGH, while the United States approves of the use of BGH
to increase milk production in dairy cows.[28]

Despite all of these
problems associated with genetically engineered foods, perhaps the
most feared threat is the possibility of antibiotic resistance. The
next section will deal specifically with the threat of antibiotic
resistance in humans as it relates to genetically engineered foods
and plants.

B. Antibiotic
Resistance and Genetically Engineered Foods

Antibiotic resistance
is a risk that occurs because of the inability to predict the
results of genetic modification. If plants or foods contain
bacterial genes that cause antibiotic resistance it could quickly
enter the human population if those crops are consumed by humans,
are feed for animals that are consumed by humans, or simply affect
the ecological chain and corrupt plants or foods that fit into the
above categories.

The reasons why
scientists fear genetically engineered plants pose a threat
deserves explanation. When plants are genetically modified by
mixing proteins across species lines, some of the transferred
proteins will come from bacterial genes, meaning that antibiotic
resistance is a distinct possibility if the crop enters the human
food chain.[29]Considering that
genetic engineering will focus on those plants fit for human
consumption, a very real risk is apparent. An additional risk
resides, of course, in the increased use of antibiotics to fight
infection because of engineered foods, which would be correlative
with an increased use of antibiotics by people hoping to prevent
possible infection as genetically engineered foods saturate the
market.

However, the main risk
of antibiotic resistance exists largely because of the process by
which scientists handle DNA in the creation of genetically
engineered plants. When identifying DNA in bacteria and plants,
scientists use antibiotic resistant genes as “markers”.
There is a threat that these markers, even though genetically
scrambled, could resurrect themselves and boost the spread of
antibiotic resistance in humans.[30]These markers,
used in genetically engineered foods to show genetic
transformation, are believed by many commentators to pose a
significant risk of spreading from plants to man.[31]

The FDA’s
framework for approving and monitoring genetically engineered foods
is loose and susceptible to flaws. The next section will discuss
recommendations for helping to improve the safety of the public
that will be consuming genetically engineered foods in increasing
quantities over the next few years.

One of the first
things that needs to be realized is the complete lack of a
structural process for the approval of genetically modified foods
by the FDA. Much like the GRAS exemptions for food additives, it is
up to the discretion of the producer of the genetically engineered
food to determine if further testing is required.[32]As the FDA has
said since taking a stance in 1992, “[The] FDA has not found
it necessary to conduct comprehensive scientific reviews of foods
derived from bioengineered plants.”[33]Like letting the
fox guard the hen house, letting biotech firms determine if lengthy
testing and delays for entrance into the marketplace is required is
setting up a system where the perverse incentives will ultimately
lead to poor decision-making. Indeed, companies only need to bring
summaries of their studies to the FDA to gain access to the market,
never allowing the FDA to see any real data.[34]Unlike GRAS
exemptions for food additives, the regulatory scheme here makes
little sense because there is no long term use or understanding of
genetically engineered foods that can ensure the safety of the
public. Recombinant DNA is a far cry from butter or salt, yet the
FDA insists on applying the same regime to both
cases.

Fully aware of the
efficiency concerns at stake in testing of genetically engineered
foods for pre-market approval, perhaps the best system is one where
microcosm testing is performed. Microcosm testing simulates the
environment the food or plant will be introduced to and provides a
small-scale model for how the genetically engineered organism will
react in nature.[35]Scientists can
replicate nature by using plants, soil, and other organisms that
will be present at the planned release site and simulate the
climate and moisture present at that site.[36]Scientists can
then gauge the likely result of putting the crop into nature,
including measuring likely changes on the environment and on the
plant itself. However, the FDA must ensure the process for testing
and approving such crops is systematized, or else there is a risk
of manipulation of the scientific processes.

Considering the
potentially devastating economic and safety issues that genetically
engineered crops present, this process would provide at least a
basic safeguard against the possible consequences of modified
crops. After all, it is the fear of the unknown changes that occur
in nature that most spur the fears about genetically engineered
foods causing an increase in human antibiotic resistance. If the
interrelations of the environment are better understood, the
possibility of antibiotic resistant traits in plants and the
likelihood of crossover to humans can be
calculated.

This process will
incur expense, but it is an expense that should be directed at the
biotech companies. These companies will have to engage in the
required testing and present their full data to the FDA, but it is
a system they will be willing to endure considering the potentially
huge profits they would reap by increasing the quality and
production of their products with genetically engineered products.
Viewing the volatile environment surrounding the debate about the
danger of genetically modified crops, such a systematic process for
approval might also provide long-term stability for companies once
they understand their products will be approved if they follow FDA
guidelines. This, in turn, will encourage companies to pursue the
necessary research. As it is now, biotech companies realize the
uncertain environment and have every incentive to push through
their products without adequate testing since they understand that
the standard for approval could change at any time. Particularly in
an area like antibiotic resistance a simple chemical analysis for
toxicity will not suffice. The status quo, therefore, is hardly
likely to adequately protect the public.

Review of the data
will necessarily mean more resources spent by the FDA, but
considering the high-profile nature of genetic engineering issues,
it is likely that more resources can be granted to FDA by Congress.
The public is extremely concerned about genetic engineering, and
such a touchy issue is likely to be seen by Congress as justifying
further FDA expenditures of time, money, and people. Less resources
will be required in this area as time goes on since certain
genetically engineered products, much like in the area of food
additives, will become accepted as safe, and biotech companies will
no longer have to go through the same procedures, instead relying
on a GRAS-like exemption.

A second solution for
the FDA is to label genetically engineered products. This is
keeping directly in line with the purpose of the FDA to protect and
inform the public so individuals can have a legitimate consumer
choice. This is particularly appealing here, where all sides are
divided as to the actual danger posed by genetically altered
products.

The specifics of the
scheme could be ironed out, but one suggestion which could avoid
any Constitutional speech problems would be a voluntary labeling
idea for companies to market foods that were not genetically
engineered.[37]This
“positive” scheme avoids the problem of forcing
producers to engage in what might be labeled as speech when the
government mandated labeling of genetically engineered products. Of
course, the biotech companies will complain that this scheme will
imply an inferiority of their products since the non-genetically
engineered label will serve essentially as a stamp of approval, but
at least the choice will be in the consumer’s hands, and not
a choice unlike decisions now based on nutrition labeling. It still
is important to note that a scheme forcing biotech companies to
label their products would probably be held constitutional since
providing consumers with health information encompasses such a
compelling interest on behalf of the government.

Labeling is an
appealing solution because of the current information available to
the public, mainly meaning little or none. In a survey done by the
International Food Information Council 71% of American viewed
themselves as poorly informed about genetically engineered
foods.[38]In an area where
there is legitimate debate that is often layered with
misinformation because of vested interests, perhaps public
awareness is the needed catalyst for the proper research on the
dangers of genetically modified foods to take place. In addition,
if the research is inconclusive at least the government will have
an accurate representation of how the public weighs the benefits
versus the risks by which products are purchased. Perhaps in
appraising the issue, the public opinion should weigh heavily in
the government’s final approach to the problem. After all, it
is not as if the government has been able to come to a consensus on
the issue. In other words, a labeling scheme might be the best way
to approach risk-assessment.

Along the same lines,
public opinion about the FDA might be bolstered if labeling for
genetically engineered products was included. A labeling scheme
would show the FDA is trying to play an active role in guarding the
public in the fast-paced world of modern food technology. The
public already shows a desire to know the process by which a
product was made; just look at the booming organic food industry as
evidence that people are avoiding the uncertain modern industrial
processes. It would be hard to deny that people are at least paying
more attention to the methods that produce their foods. For
example, one recent poll by Time magazine showed the public
supported the labeling of genetically engineered foods by an
overwhelming 81 %.[39]At the very least,
labeling will ensure the public is aware of the amount of
genetically engineered products they consume, and because of this
awareness there will be an avoidance of diets overly concentrated
with these foods. This overconcentration is important since it
could take large quantities of a specific altered food to increase
the risk of antibiotic resistance to a statistically significant
level. If there is a decrease in use, or at least the avoidance of
a diet dominated by one particular genetically altered food, there
is a decreased chance that antibiotic resistance will
occur.

A labeling scheme also
prevents the essential blackmailing of the FDA by biotech companies
with threatened lawsuits. As one scholar said, “the lack of
federal guidance permits a mounting litigious
battle.”[40]Genetically
altered food product manufacturers have taken a litigious strategy
already to manipulate the FDA into discarding the labeling
idea.[41]By going ahead and
implementing the labeling structure, this threat by the biotech
industry is ameliorated, and any short-term lawsuit wave will be
outweighed by the long-term lack of lawsuits and threats to try and
preserve the status quo.

Labeling might also be
a good economic idea when one considers the international view of
genetically engineered foods. Internationally biotech companies are
viewed with far more skepticism, and much of it is driven by a
grassroots movement against genetic engineering.[42]The movement has
achieved a large amount of success, and recently the European Union
announced a moratorium on new approvals of genetically engineered
foods until better EU safety regulations are put into place in
2002.[43]If the US was to
institute labeling for genetically modified food products this
might facilitate more trade with the international community. Under
the labeling system countries could know which foods were
genetically altered and the label might serve to generate a feeling
of security around genetically engineered products. Forthright
labeling implies honesty and safety, and this security would make
foreign powers more willing to deal with the US food market.
Feeling of subterfuge and mistrust, even subtly implied, could be
disastrous in international trade negotiations.

Instituting further
regulations is necessary to prevent the potentially disastrous harm
of widespread antibiotic resistance through genetically engineered
foods. Both microcosm testing and labeling would, for the reasons
discussed, implement safeguards against potential harm by
generating additional awareness about the potential consequences of
genetically engineered foods and, hopefully in turn, produce
increased knowledge.

Part II. Animal
Drugs and Antibiotic Resistance .

An
Overview

Drugs, specifically
antibiotics, are administered to animals routinely to treat
sickness, prevent illness, and promote the growth of
animals.[44]Indeed, 40% of all
antibiotics used in the U.S. are fed to animals being raised for
their food potential.[45]The only use that
many feel should be permitted is the therapeutic use of helping
sick animals. It is the sub-therapeutic uses, i.e. when the animals
are not sick, that causes scientists to be concerned. The most
common way to administer the antibiotics is through animal
feed.

The use of antibiotics
is essential in modern farming. Without sub-therapeutic doses of
antibiotics modern factory farming, which concentrates large number
of animals in a small amount of space, would not be
possible.[46]Animals can only
survive the disease and health problems that naturally accompany
close confinement if they receive antibiotics.[47]In addition,
subtherapeutic doses of antibiotics promotes growth, which means
larger animals, more eggs from chickens, and more milk from
cattle.[48]In addition,
antibiotics are often sprayed in subtherapeutic doses on fruit to
prevent disease.[49]A subtherapeutic
dose is typically one to ten percent of a therapeutic dose to treat
a sick animal.[50]In other words,
the agricultural industry is wholly dependent on the widespread use
of antibiotics to produce at its current rate. In turn, the
industry keeps the grocery shelves full while keeping consumer cost
down. However, there is controversy surrounding the
industry’s current practice, and the concern extends far
beyond just the outrage over the conditions that many animals live
with modern farming.

B. Antibiotic Resistance and Animal Drugs

The debate over animal
drugs and antibiotic

Resistance in humans
is nothing new. Indeed, since the early 1970s the FDA has focused
on the issue every 5-10 years, though never coming to a consensus
as to what approach to take.[51]The basic fear is
that antimicrobials in livestock will trigger a resistant bacteria
that could infect humans, whether through direct exposure or by
eating meat with the resistant bacteria.

As an example of the
FDA’s concern over animal drugs is the newly proposed
framework for evaluating new animal drugs in food-producing
animals.[52]Essentially, the
new framework would classify new and existing antibiotics based
upon their importance to human medicine, set thresholds based upon
acceptable levels of susceptibility of pathogens to antibiotics,
and then monitor this susceptibility to ensure safety in the
future.[53]Many have
criticized these regulations as too restrictive since most
antibiotics used in veterinary medicine are common to those used in
human medicine, though there are rare exceptions such as
ionophores.[54]

Despite this new
regulation, there is still considerable debate over whether
antibiotics used with animals are a threat to humans. For example,
there is no directly documented case where antibiotic use in
animals has caused treatment failure in humans.[55]However, studies
are showing a link. For example, a group of Minnesota health
specialists reported in the New England Journal of Medicine that
the approval and use of a drug in chickens was followed by an
eightfold increase in drug-resistant food poisoning involving the
same drug.[56]The particularly
disconcerting fact is that the drug in question was quinolone, a
drug of first resort for doctors.[57]

With the evidence on
both sides still contested, there is debate on exactly how
antibiotic resistance would spill over into the human population.
For example, there is the potential for antibiotic resistant food
poisoning from eating meat with resistant bacteria, leading to
dangerous cases of listeria, E. coli, salmonella, and
campylobacter.[58]It is eating these
foods with resistant bacteria that poses the real threat, not from
eating food laced with traces of antibiotics. Additionally, farmers
and workers in slaughterhouses can become exposed to the dangerous
resistant bacteria just through contact with the
animals.[59]Without proper
cleaning, ingestion of bacteria can inadvertently occur. Crops also
retain the bacteria in question if they are fertilized with the
manure of animals given antibiotics.[60]

The stakes are high,
but the evidence is confusing and sometimes conflicting. However,
considering the risk involved with antibiotic resistance there
should be appropriate precautions taken by the FDA.

Recommendations for the FDA
Concerning Animal Drugs

The FDA, as could be expected with its
limited

resources, is only able to focus so many hours on
animal drugs. Since the link between animal drugs and human illness
is so tenuous, the FDA perhaps wisely has avoided allocating too
many resources into this area. However, considering the recent
evidence on the subject and the devastating possible risk (even if
proven statistically small), the FDA should institute better
safeguards in the area of animal drugs.

The first step the FDA
needs to take is a better monitoring procedure for the distribution
of animal drugs.[61]While it might not
be realistic to expect a company like Monsanto to report possible
flaws in their products, the threat of possible criminal charges
might have the necessary inducement. This could be done through
manufacturers, veterinarians, and feed producers. If a central form
can be produced and sent in by the above groups, and the processing
done perhaps jointly with the USDA and EPA, the FDA would
understand the usage, amount of doses, and could also monitor
adverse reactions within animals. Such a system might also allow
better checking of possible human resistance through animal drugs,
or at least an earlier indication of possible spill over into the
human population. Plus, if there is a system of monitoring in place
it should make the distributors and users of antibiotics more aware
and cautious in the amount they use and the drugs they put into the
market. Just by having the system in place it should serve to edify
people that the FDA considers antibiotic resistance a real health
threat to the nation.

Additional testing of
animal drugs is perhaps also needed. Expense is a concern here, but
the addition of user fees for animal drugs could perhaps offset the
cost. That seems like a small price to pay considering the risk at
stake. Political feasibility would be an issue, but the hot issue
of antibiotic resistance could help offset the political
vulnerability of the user fee idea. The same idea discussed with
genetically engineered food, microcosm testing, could apply here.
Perhaps new animal drugs, specifically antibiotics, could be tested
on the main food-producing animals. The animals could be tested for
resistance, and any products derived from those animals could be
tested for a build-up of resistant bacteria. Giving the food
products to test animals might also help to demonstrate the
possible effects of consumption of the products. Clearly, this
would not be a perfect system since the duration and quantity of
use could not be simulated. However, truly dangerous products might
exhibit resistance in a short amount of time. Perhaps even more
importantly, companies will realize these tests will be performed
and therefore will be more cautious in the design of new animal
drugs.

The cost of the
testing will be shouldered by the companies. The cost will be
miniscule in comparison to the potential profit, but this
regulation might be viewed more favorably for other reasons. For
one, it is an assurance that the animal drugs will not be banned or
severely restricted. Second, it will enhance the industry’s
image within the public eye. Finally, the regulations can help
foster a cooperative spirit between industry and the FDA since the
findings of the FDA will be based upon the research of the
companies, and will not just be a regulatory hand swooping down for
unknown and arbitrary reasons.

The final solution
suggestion, and the one that should provide immediate benefit, is
an educational campaign to notify people of the risks of food
poisoning. A simple campaign to let people know that washing their
knives, cutting boards and hands after handling food could reduce
possible risks without riling up industry.[62]While this
knowledge might be common place, a reinforcement of its usefulness
would help, plus an announcement that additional risk now existed
because of animal drugs might serve to motivate more people to take
the correct precautions with their food.

A final topic should
be addressed on animal drugs. Many have suggested that the only
safe route to take is to completely ban antibiotics from use in
animals, in particular the use of antibiotics in animals feed. At
the very least, people think that a few antibiotics should be
banned, such as penicillin and fluoroquinolones, because of their
widespread human use.[63]However, this
seems like an overreaction to the problem. For one, there is a
concrete benefit to using antibiotics in overall growth of animals
and increased food production. Compare this to the highly debated
risk of widespread human antibiotic resistance because of these
animal drugs.[64]The FDA, a known
conservative agency, would certainly consider such a ban if there
was truly a substantiated link between animal drugs and the
possibility of large-scale human illness. Until that link is agreed
upon by scientists, forcing farmers to quit using animal drugs
would severely restrict farmer’s incomes, increase food
prices, and cause chaos in the agricultural and food
markets.[65]Besides, the cost
of enforcing the ban on any or all antibiotics would be
astronomically high in terms of money and manpower. In other words,
a ban would be a pragmatic impossibility because of the available
FDA resources.

The FDA’s
current proposal, by subjecting certain antibiotics considered
necessary for human use to more stringent scrutiny, enables the use
of helpful antibiotics while still ensuring that problems with
particular antibiotics are caught early and dealt with swiftly. The
suggestions in this paper would additionally further the goal of
watching the public safety while not overreacting and creating
panic and turmoil. The high stakes mandate a careful approach, but
the uncertainty also requires a practical one.

In conclusion,
antibiotic resistance is such a threat because of the possibility
of it harming the human population without much notice, perhaps
leaving scientists unable to determine the cause of human illness
or increased antibiotic resistance. The measures mentioned in this
paper all serve to help provide the FDA with the ability to closely
monitor animal drugs because of their threat, yet these measures do
not compromise farmer’s livings or the current agricultural
market by overreacting to an unknown and unverified threat. This
seems to be in direct alignment with the FDA’s purpose of
formulating policies that best protect and enrich the lives of
American citizens.

Part III.
Recommendations for Dealing with the General Problem of Antibiotic
Resistance

Antibiotic resistance
is a problem that has plagued the FDA for many years, perhaps
because of its inevitability. Antibiotics are invaluable to medical
science, but the use of antibiotics necessarily creates strains of
resistant bacteria. While genetically engineered foods and the use
of animal drugs creates potentially pandemic problems of antibiotic
resistance, the major problem currently is simply overuse and
overprescription of antibiotics.[66]Doctors improperly
prescribe antibiotics as a panacea drug on a routine basis. For
example, antibiotics are often prescribed for upper respiratory
infections (i.e. the common cold) and middle ear infections, yet
these are viral infections that antibiotics are useless
against.[67]It is this direct
problem of misuse that the FDA can attack far more easily and
perhaps effectively.

The first suggestion
to deal with the overuse of antibiotics by people is to institute a
distribution limit. This could be done by requiring physicians run
a check for bacterial infection before pharmacies are allowed to
distribute antibiotics. This requirement could easily be fulfilled
electronically with communication between the pharmacy and the
manufacturer of the antibiotics, and would ensure that doctors were
prescribing antibiotics for bacterial infections, and not the
common cold.[68]Such a system
would serve to educate some doctors, while simply reminding other
doctors of the proper use of antibiotics. This simple distribution
limitation would cut to the heart of the antibiotic resistance
problem, without having to create a complex regulatory scheme or
adding addition layers to new antibiotic approval. Considering the
inevitability of antibiotic resistance, still allowing antibiotics
to be approved in the same manner as the status quo is important.
New antibiotics will be a simple solution to antibiotic resistance,
and this distributional limit will only indirectly and minimally
effect incentives to invest in new antibiotic development. The
market will still remain huge for antibiotics so the profit
potential is not destroyed, and any loss of incentives to create
new antibiotics is more than outweighed by the good health and
preventative measures having a distributional limit would impose.
At the very least, physical examination should be required before
antibiotics can be prescribed by a physician.[69]Of course, narrow
exceptions can be tailored when physical examination is impossible.
Having the American Medical Association’s involvement could
be critical, not only for public relations but for the ability of
the AMA to provide teeth to this proposal by threatening penalties
against doctors that fail to properly prescribe
antibiotics.

The second suggestion
for curbing the overuse of antibiotics is the classification and
restriction of certain antibiotics, specifically within hospital
pharmacies. Those antibiotics classified as restricted could only
be approved for use after consultation with the infectious disease
department of the hospital.[70]Restricted
antibiotics will be those the medical community views as essential
to protect, specifically those antibiotics that have been
successful without a demonstration of resistance within the human
population. This additional distributional limitation could
function in conjunction with the first suggestion, ensuring that
doctors consider the importance of their prescription and then
additionally are restricted in the type of antibiotics they can
prescribe. Antibiotic misuse will be curbed, and specifically the
misuse of essential antibiotics will be minimized. One would hope
that a program like this could be done voluntarily by hospitals
with any needed assistance provided by the FDA. A voluntary program
would preserve the resources of the FDA, and can also be just as
effective as a governmental program, evidenced by the current
voluntary program at Mount Sinai Hospital.[71]Indeed, the
program at Mount Sinai goes even further than this proposal by also
requiring constant education of physicians on antibiotics and
conducting surveillance, analysis, and monthly reports on the use
of antibiotics within the hospital.[72]

Finally, the last
suggestion would be required additional labeling warnings on
certain antibiotics by the FDA. A warning label on certain
antibiotics concerning appropriate use and dosage would serve as an
additional layer of protection against improper prescription by
physicians and to provide the patient with an understanding of the
risks of taking antibiotics.[73]Considering the
current problem of overprescription and improper prescribing by
physicians, such labeling seems essential to provide consumers with
enough information so that they can know whether they wish to
follow their doctor’s advice. Labeling might also serve as a
deterrent effect for manufactures and physicians by exposing them
to more tort liability if there are misuses of antibiotics. Knowing
this, physicians and manufacturers will be sure that antibiotics
are used in a more responsible way.

The threat feared
posed by genetically engineered foods and animal drug use is
apocalyptic but unknown, but the immediate and definite threat of
antibiotic misuse can be countered with the above suggestions. The
key is alerting physicians to the problem, and forcing them to be
aware and responsible for their role in the problem. With
cooperative efforts between doctors and the FDA, education about
the problem of antibiotic resistance will reach physicians and
patients alike, and that will go a considerable way towards solving
the problem.

Conclusion

Antibiotic resistance
is one the more perplexing problems the FDA has encountered.
However, the FDA is in a unique position to play a positive
role.

For one, the FDA has
expertise and statutory authority over drugs. The FDA is the agency
that people will expect to deal with a problem involving
antibiotics precisely because of their expertise and authority.
Second, the FDA is unique among agencies because it has public
respect and confidence. The FDA, more than any other agency, can
bring physicians, manufacturers, and scientists to the negotiating
table to reach solutions to this complex problem. This ability to
bring groups together will be critical in the area of antibiotic
resistance where there is such controversy.

Antibiotic resistance
poses a threat to mankind. Whether the threat is indirect and
debated, such as the harm feared because of genetically engineered
food or animal drugs, or more direct and verifiable, such as the
misuse of antibiotics by people, the FDA can play a central role in
curbing the threat. The key is to act swiftly, before the potential
harm is realized.

[2] Id. Linda Tollefson, director of surveillance and
compliance in FDA’s Center for Veterinary Medicine, said,
“You’re dealing with living microbes that have shown an
incredible ability to accommodate antibiotics and come out winning.
We have no idea what they are going to do next. Our fear is that
we’re seeing the tip of the iceberg.”